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Double stitch may keep babies safer: new study on weak cervix

NCT ID NCT05268640

Disease control Sponsor: Centre of Postgraduate Medical Education Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether placing two stitches instead of one around the cervix during an emergency can help women with a weak cervix carry their pregnancy longer. The trial included 81 women between 16 and 25 weeks of pregnancy whose membranes were bulging out. The goal was to see if the double stitch reduces the number of births before 34 weeks compared to the standard single stitch.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

81 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * singleton pregnancy, * gestational age 16+0 to 25+6 weeks, * live fetus, * cervical incompetence with fetal membranes visible through external os before 24+0 weeks of gestation, * informed written consent. Exclusion Criteria - any of the following occuring before the administration of the cerclage: * preterm premature rupture of membranes, * vaginal bleeding, * active regular uterine contractions, * fetal demise, * fever, * intrauterine infection (diagnosed in case of maternal body temperature ≥ 38°C with no alternative cause identified and at least 2 symptoms among the following appear: fetal tachycardia \> 160 bpm for 10 minutes or longer, uterine pain, purulent vaginal discharge, white blood cell count \> 15 G/L in the absence of corticosteroid treatment or increased plasma C-reactive protein \> 10 mg/L), * known genetic defects of the fetus, * known lethal fetal malformations, * congenital uterine defects, * multiple pregnancy.

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Conditions

The condition(s) this trial relates to.

cervical incompetence pregnancy disorder Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical incompetence

Contacts and locations

Locations

  • 1st Department of Obstetrics and Gynecology, Center of Postagraduate Medical Education

    Warsaw, Masovian Voivodeship, 01-004, Poland

  • 1st Department of Obstetrics and Gynecology, Medical University of Warsaw

    Warsaw, Masovian Voivodeship, 02-015, Poland

  • Department of Obstetrics and Gynecology, Oncological Gynecology and Gynecological Endocrinology, Medical University of Gdansk

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Department of Obstetrics, Perinatology and Neonatology, Center of Postagraduate Medical Education

    Warsaw, Masovian Voivodeship, 01-809, Poland

  • Department of Obstetrics, Women's Diseases and Oncological Gynecology, Nicolaus Copernicus University

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

  • Institute of Mother and Child

    Warsaw, Poland

  • Polish Mother's Memorial Hospital - Research Institute

    Lodz, Łódź Voivodeship, 93-338, Poland